FDA orders Darvon pulled from the U.S. marketplace

by Andrew Zajac - Nov. 20, 2010 12:00 AMTribune Washington Bureau

WASHINGTON - Although still in wide use more than a half-century after introduction, Darvon and Darvocet and their generic counterparts are easily replaceable, pain-management experts said Friday after the Food and Drug Administration asked that the popular painkillers be removed from the U.S. marketplace.

The FDA's decision, based on data showing a risk of serious heart-rhythm abnormalities, caps years of controversy about the dangerous side effects of Darvon - known generically as propoxyphene - which was first approved by regulators in 1957.

Sidney Wolfe of Public Citizen's Health Research Group blasted the FDA's action as too late and called for congressional hearings into why the agency took so long to move.

In calling for withdrawal of the drug, the FDA urged doctors to stop prescribing it immediately. It advised patients to continue taking propoxyphene while consulting quickly with physicians to arrange for alternative medication.

Propoxyphene, an opioid, is used to treat mild to moderate pain.

The FDA estimated that propoxyphene was used by 10 million people in 2009, with most of them receiving the drug in combination with acetaminophen, a compound known by the Darvocet trade name.

Many doctors who prescribe propoxyphene do so simply because it's been around so long and they're familiar with it, said Al Anderson, a Minneapolis family practitioner and president of the American Academy of Pain Management board of directors.

Anderson said the withdrawal will hurt a small number of patients who can't tolerate other painkillers, but for most patients, there are many alternatives, such as oxycodone, morphine and Nucynta.

"It certainly takes one tool away, but it's a small tool," Anderson said.

"We have many better options," said Mehul Desai, director of pain medicine at George Washington University Hospital in Washington. "It tends to be a pretty poor pain reliever."

Propoxyphene was effectively pulled from the market because of health concerns by regulators in Britain in 2005 and by the European Union in June 2009.

In January 2009, an FDA advisory panel voted 14-12 against continued marketing of propoxyphene.